Early Stepping Verticalization in ICU for ABI Patients

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Completed

Conditions: Brain Injury; Consciousness Disorders

Treatments: Other: conventional mobilization; Device: stepping verticalization

Study type: Interventional

Funder types: Other

Identifiers

NCT02828371

Erigo_eff

Details and patient eligibility

About

Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by disorder of consciousness due to ABI.

Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
• diagnosis of vegetative state or minimally conscious state on the third day after the injury;
• adequate pulmonary gas exchanging function;
• stable hemodynamics

Exclusion criteria

• sedation;
• unstable intracranial pressure (ICP);
• cerebral perfusion pressure (CPP) <60 mmHg;
• fractures or skin lesions in thorax, abdomen or lower limbs;
• deep vein thrombosis;
• body weight >130 kg; height >210 cm.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Erigo

Experimental group

Description:

Single daily sessions of verticalization, using a tilt table with an integrated robotic stepping device (Erigo. Hocoma AG, Switzerland) located in the ICU room. Sessions were performed five times per week (Monday-Friday) for three consecutive weeks (a total of 15 sessions per patient). On the same days the patients received conventional physiotherapy for 30 minutes a day. Before the verticalization period the experimental group received conventional in-bed physiotherapy for 60 minutes a day.

Treatment:

Device: stepping verticalization

Conventional

Active Comparator group

Description:

treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.

Treatment:

Other: conventional mobilization